TPF-LITT ARM for Urinary Incontinence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Urology Specialist Group, Hialeah, FLUrinary Incontinence+8 MoreTRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) - Device
Eligibility
50 - 80
Male
What conditions do you have?
Select

Study Summary

This trial assesses the safety & tolerance of a new prostate cancer treatment that's done in the office setting under local anesthesia to preserve organ function & reduce surg. risk.

Eligible Conditions
  • Urinary Incontinence
  • Prostate Cancer
  • Adverse Effects Surgery
  • Magnetic Resonance Imaging (MRI)
  • Ultrasound
  • Sexual Dysfunction
  • Urinary Dysfunction
  • Prostate Biopsy
  • Ablation

Treatment Effectiveness

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 1 year

1 year
Average Ablated area volume (in cc) measured by MRI 1-year following the procedure
Number of patients with a 75% decrease in Serum PSA levels (ng/ml) after procedure measured at fixed intervals
Number of patients with presence of cancer cells in treated -ablated- area
12 Months
Number of men with absent ejaculation
Number of patients with a 5 point drop in the sexual health inventory for men (SHIM) scores
Number of patients with a 50% increase in qMAX measured in cc/second on flow studies
Number of patients with a 7 point drop in the International Prostate Symptom Score (IPSS)
24-72 hours after procedure
Average Ablated area volume (in cc) measured by MRI immediately following the procedure
30 days
Average Ablated area volume (in cc) measured by MRI 1-month following the procedure
90 days
Average Ablated area volume (in cc) measured by MRI 3-month following the procedure
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.

Trial Safety

Trial Design

1 Treatment Group

TPF-LITT ARM
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: TPF-LITT ARM · No Placebo Group · N/A

TPF-LITT ARM
Device
Experimental Group · 1 Intervention: TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Urological Research Network, LLCLead Sponsor
4 Previous Clinical Trials
10,170 Total Patients Enrolled
Fernando J Bianco, MDPrincipal InvestigatorUrological Research Network
1 Previous Clinical Trials
150 Total Patients Enrolled
Isabel H Lopez, BS., MBAStudy DirectorUrological Research Network

Eligibility Criteria

Age 50 - 80 · Male Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You do not have difficulty urinating or retaining urine.
References

Frequently Asked Questions

Does this research endeavor accept individuals over the age of 55?

"This clinical trial is open to individuals aged 50-80. Those younger than 18 or older than 65 may still find a suitable study, as there are 90 trials for minors and 1459 studies available to those over the age of 65." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available in this experiment for participants?

"Affirmative. According to clinicaltrials.gov, the research is currently recruiting patients after its initial posting on March 16th 2022 and last update January 24th 2023. The trial seeks out twenty participants from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Who can take advantage of this research opportunity?

"This clinical study is seeking 20 individuals aged 50-80 with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Patients must meet various criteria, including the ability to sign informed consent documents and complete follow up visits; an absence of urinary retention; a serum creatinine level below 2 ng/dL and a GFR above 45; PSA levels under 20 ng/ml; Multiparametric MRI scores 3-5 for piRADS evaluation of their prostate volume between 18-100 cc in size, indicating intermediate risk prostate cancer with less than 1/3 glandular tissue present." - Anonymous Online Contributor

Unverified Answer

How many participants are currently engaging in this research project?

"Affirmative. Clinicaltrials.gov corroborates that the research project, which was initially put forward on March 16th 2022, is proactively recruiting participants. So far it has sought 20 individuals at one trial site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.